BEERSE, Belgium--(BUSINESS WIRE)--The Janssen Pharmaceutical Companies of Johnson & Johnson today
announced that the Committee for Medicinal Products for Human Use (CHMP)
of the European Medicines Agency (EMA) has recommended broadening the
existing marketing authorisation for Darzalex® (daratumumab)
for use as frontline (initial) therapy.1 The recommendation
is for the use of daratumumab in combination with bortezomib, melphalan
and prednisone, for the treatment of adult patients with newly diagnosed
multiple myeloma who are ineligible for autologous stem cell transplant
(ASCT).1

“Multiple myeloma becomes harder to treat each time it returns, so the
goal of initial therapy is to prevent the cancer from progressing for as
long as possible,” said Dr Maria-Victoria Mateos, Ph.D., lead ALCYONE
study investigator and Director of the Myeloma Unit at University
Hospital of Salamanca-IBSAL Salamanca, Spain. “Selecting the right
treatment regimen for newly diagnosed patients is critical to their
long-term survival, especially those who are transplant ineligible, so
daratumumab could offer an important new standard of care in this
indication.”

The CHMP’s recommendation is based on results from the randomised,
open-label, multicentre Phase 3 ALCYONE (MMY3007) study, recently
published in the New
England Journal of Medicine.2 Additional information
about this study can be found at www.ClinicalTrials.gov (NCT02195479).3

“Clinical findings have consistently demonstrated the compelling benefit
daratumumab offers across all lines of therapy in multiple myeloma, and
this positive recommendation brings us one step closer to providing this
ground-breaking option to more patients in Europe,” said Dr Catherine
Taylor, Europe, Middle East and Africa (EMEA) Haematology Therapeutic
Area Lead, Janssen. “Through our research and development efforts, we
remain committed to identifying and treating patients earlier and
earlier in their cancer journey, when they are healthier and have the
best chance at lasting remission.”

In Europe, daratumumab is currently indicated for use in combination
with lenalidomide and dexamethasone, or bortezomib and dexamethasone,
for the treatment of adult patients with multiple myeloma who have
received at least one prior therapy;4 and as monotherapy for
the treatment of adult patients with relapsed and refractory multiple
myeloma, whose prior therapy included a proteasome inhibitor (PI) and an
immunomodulatory agent, and who have demonstrated disease progression on
the last therapy.4

A final decision regarding the approval of daratumumab for newly
diagnosed patients is expected from the European Commission in the
coming months.

In the U.S.A., daratumumab in the frontline setting was granted Priority
Review by the U.S. Food and Drug Administration (FDA) in January this
year,5 and was recently approved for
use in this indication.6

#ENDS#

About Daratumumab

Daratumumab is a first-in-class biologic targeting CD38, a surface
protein that is highly expressed across multiple myeloma cells,
regardless of disease stage.7-9 Daratumumab is believed
to induce tumour cell death through multiple immune-mediated mechanisms
of action, including complement-dependent cytotoxicity (CDC),
antibody-dependent cell-mediated cytotoxicity (ADCC) and
antibody-dependent cellular phagocytosis (ADCP), as well as through
apoptosis, in which a series of molecular steps in a cell lead to its
death.4 A subset of myeloid derived suppressor cells
(MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were
decreased by daratumumab.4 Daratumumab is being
evaluated in a comprehensive clinical development programme that
includes nine Phase 3 studies across a range of treatment settings in
multiple myeloma, such as in frontline and relapsed settings.3,10-17 Additional
studies are ongoing or planned to assess its potential for a solid
tumour indication and in other malignant and pre-malignant diseases in
which CD38 is expressed, such as smouldering myeloma.18-23 For
more information, please see www.clinicaltrials.gov.

In August
2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide
agreement, which granted Janssen an exclusive licence to develop,
manufacture and commercialise daratumumab.24

About Multiple Myeloma

Multiple myeloma (MM) is an incurable blood cancer that starts in the
bone marrow and is characterised by an excessive proliferation of plasma
cells.25 MM is the second most common form of blood cancer,
with around 40,570 new cases in Europe in 2015.26 MM most
commonly affects people over the age of 65 and is more common in men
than in women.27 The most recent five-year survival data for
2000-2007 show that across Europe, up to half of newly diagnosed
patients do not reach five-year survival.28 Almost 29% of
patients with MM will die within one year of diagnosis.29

Although treatment may result in remission, unfortunately, patients will
most likely relapse as there is currently no cure.30 While
some patients with MM have no symptoms at all, most patients are
diagnosed due to symptoms that can include bone problems, low blood
counts, calcium elevation, kidney problems or infections.31 Patients
who relapse after treatment with standard therapies, including PIs and
immunomodulatory agents, have poor prognoses and few treatment options
available.32

About the Janssen Pharmaceutical Companies

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are
working to create a world without disease. Transforming lives by finding
new and better ways to prevent, intercept, treat and cure disease
inspires us. We bring together the best minds and pursue the most
promising science. We are Janssen. We collaborate with the world for the
health of everyone in it. Learn more at www.janssen.com/emea.
Follow us at www.twitter.com/janssenEMEA for
our latest news.

This press release contains "forward-looking statements" as defined
in the Private Securities Litigation Reform Act of 1995 regarding a
recommendation to broaden the existing marketing authorisation for
daratumumab. The reader is cautioned not to rely on these
forward-looking statements. These statements are based on current
expectations of future events. If underlying assumptions prove
inaccurate or known or unknown risks or uncertainties materialise,
actual results could vary materially from the expectations and
projections of Janssen-Cilag International NV, the Janssen
Pharmaceutical Companies of Johnson & Johnson and/or Johnson & Johnson.
Risks and uncertainties include, but are not limited to: challenges and
uncertainties inherent in product research and development, including
the uncertainty of clinical success and of obtaining regulatory
approvals; uncertainty of commercial success; manufacturing difficulties
and delays; competition, including technological advances, new products
and patents attained by competitors; challenges to patents; product
efficacy or safety concerns resulting in product recalls or regulatory
action; changes in behaviour and spending patterns of purchasers of
health care products and services; changes to applicable laws and
regulations, including global health care reforms; and trends toward
health care cost containment. A further list and descriptions of these
risks, uncertainties and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended December
31, 2017, including in the sections captioned “Cautionary Note Regarding
Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the
company’s subsequent Quarterly Reports on Form 10-Q and other filings
with the Securities and Exchange Commission. Copies of these filings are
available online at www.sec.gov, www.jnj.com or
on request from Johnson & Johnson. None of the Janssen Pharmaceutical
Companies nor Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or
developments.

10. ClinicalTrials.gov. A study comparing daratumumab, lenalidomide, and
dexamethasone with lenalidomide and dexamethasone in relapsed or
refractory multiple myeloma. NCT02076009. Available at: https://clinicaltrials.gov/ct2/show/NCT02076009 Last
accessed June 2018.

19. ClinicalTrials.gov. A study to assess the clinical efficacy and
safety of daratumumab in participants with relapsed or refractory
natural killer/T-cell lymphoma (NKTCL), nasal type. NCT02927925.
Available at: https://clinicaltrials.gov/ct2/show/NCT02927925 Last
accessed June 2018.

20. ClinicalTrials.gov. Study to separately evaluate the activity of
talacotuzumab (JNJ-56022473) or daratumumab in transfusion-dependent
participants with low or intermediate-1 risk myelodysplastic syndromes
(MDS) who are relapsed or refractory to erythropoiesis-stimulating agent
(ESA) treatment. NCT03011034. Available at: https://clinicaltrials.gov/ct2/show/NCT03011034 Last
accessed June 2018.

22. ClinicalTrials.gov. A study to test the safety and effectiveness of
nivolumab combined with daratumumab in patients with pancreatic,
non-small cell lung or triple negative breast cancers, that have
advanced or have spread. NCT03098550. Available at: https://clinicaltrials.gov/ct2/show/NCT03098550 Last
accessed June 2018.

23. ClinicalTrials.gov. A study to evaluate the efficacy and safety of
daratumumab in combination with cyclophosphamide, bortezomib and
dexamethasone (CyBorD) compared to CyBorD alone in newly diagnosed
systemic amyloid light-chain (AL) amyloidosis. NCT03201965. Available
at: https://clinicaltrials.gov/ct2/show/NCT03201965 Last
accessed June 2018.